FDA approves first flu vaccine that can be self-administered at home

By Deidre McPhillips, CNN

(CNN) — The US Food and Drug Administration on Friday approved the first flu vaccine that does not have to be administered by a health care provider, but it won’t be available in time for this respiratory virus season.

FluMist is a nasal spray manufactured by AstraZeneca that has been used to protect against influenza in the United States since 2003. It’s currently available in pharmacies and other health care settings for people ages 2 to 49 who have a prescription.

Friday’s approval from the FDA adds a second option for those eligible to receive the vaccine: It can be taken at home, through self-administration by adults or to children with the help of a caregiver.

AstraZeneca plans to make the vaccine available for self-administration through a third-party online pharmacy, which will prescribe and ship the vaccine after reviewing a screening and eligibility assessment. It expects this option to be available in time for the start of next year’s respiratory virus season.

“Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death,” he said. “This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”

The flu caused at least 35 million illnesses, 400,000 hospitalizations and 25,000 deaths in the 2023-24 season, according to estimates from the US Centers for Disease Control and Prevention. The CDC recommends vaccination for everyone ages 6 months and older each season. But uptake has fallen in recent years; last season, only about half of adults and children got their annual flu vaccine.

FluMist is the only needle-free option available for flu vaccination in the US. It uses a live, weakened version of the influenza virus to provide protection, but injectable versions use different technology: either killed viruses or proteins to train the immune system to fight off the virus. AstraZeneca says FluMist has been shown to be as effective as other flu vaccines.

When the FDA announced last year that it was reviewing the possibility of a self-administered flu vaccine, physicians told CNN that they welcomed more accessible options but didn’t expect that self-administration would change vaccination rates significantly.

Dr. Ashish Jha, dean of the Brown University School of Public Health and the former White House Covid-19 response coordinator, said at the time that a self-administered flu vaccine option could be even more accessible if it were available to buy on pharmacy shelves, rather than through a gatekeeper.

But he noted as many as 10% to 15% of people may be needle-phobic and hesitant to get vaccines, so increasing ways to access a needle-free version could boost uptake.

“I think the impact is going to be modest,” he said of the possibility. But he said he hoped it to would lead to increased awareness, potentially through more marketing from AstraZeneca, or more research into additional intranasal vaccines that are easier to get. “I see this as a relatively positive step.”

CNN’s Meg Tirrell contributed to this report.

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